Bilateral Deep Brain Stimulation of Forel's H Field in Tourette's Syndrome: Prospective, Randomized, Crossover, Double-blind Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tourette Syndrome
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Percent of change in the score of Yale Global Tic Severity Scale (YGTSS) pré and pós stimulation, comparing device On(active) and device OFF (sham) conditions.
- Last Updated
- 3 years ago
Overview
Brief Summary
Tourette's Syndrome (TS) is a neurodevelopmental disease characterized tics that start before the age of 18 years. About 5% of cases do not respond to drug treatment and can be classified as refractory and in these cases surgical treatment, with deep brain stimulation, appears as a therapeutic possibility, but with still conflicting results. Our hypothesis is that DBS in Forel's H Field could improve tourette's symptoms, neurological and psychiatric ones.
Detailed Description
Sixteen patients with TS will be included in our protocol. The tics must have a negative influence in the quality of life of these patients. Patients will be submitted to a neuronavigation protocol for the precise location of the surgical target. After the surgery all patients will have the device turned ON for 6 months. After the first 6 months participants will be randomly in two groups, one to stay with device ON or turned OFF at a period of 3 months. After that the groups will cross over for more 3 months. Clinical and video evaluations will be conducted before the surgery, at end of open fase, in the moment of cross over and at end of all.
Investigators
Rubens Gisbert Cury
Medical Assistant, Movement Disorders Unit. Principal Investigator. MD, PhD
University of Sao Paulo General Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with Tourette's Syndrome diagnosis.
- •Age equal to or above 14 years.
- •Severe impairment of motor tics (Yale Global Tic Severity Scale ≥ 35/50).
- •Patients who are refractory to drug treatment.
- •Patients intellectually able to understand and sign the consent form.
- •Possibility to adhere to research and periodic medical visits after surgery.
Exclusion Criteria
- •Inability to consent to your participation in the study.
- •Patients with non-stabilized psychiatric comorbidities, such as anxiety and depression.
- •Concomitant treatment with other experimental drugs.
- •Women who are pregnant or breastfeeding.
- •Patients undergoing previous neurosurgical procedures for the treatment of Tourette's Syndrome.
Outcomes
Primary Outcomes
Percent of change in the score of Yale Global Tic Severity Scale (YGTSS) pré and pós stimulation, comparing device On(active) and device OFF (sham) conditions.
Time Frame: month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.
Assess 5 items: number, frequency, intensity, complexity, interference. Each item is scored for phonic and motor tic symptom by the patient on a 0 to 5 numerical scale. The maximum possible score for these part is 50. Add to that the impairment score, which also has 50 as the maximum score. Total Yale Global Tic Severity Scale Score (Total Tic Severity Score + Impairment). The maximum possible score for the total scale is 100. Lower scores of YGTSS represents less tics.
Secondary Outcomes
- Change in Quality of Life(month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.)
- assessment of structural connectivity patterns(month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.)
- Change in psychiatric symptom - obsessive-compulsive disorder(month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.)
- Change in psychiatric symptoms - Anxiety(month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.)
- Change in psychiatric symptom - attention deficit hyperactivity disorder(month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.)
- Change in psychiatric symptom - Depression(month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.)